BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 22-1325 ULNAR STEM

    MDR report key: 17981817 · Received October 21, 2023

    Report

    Report Number
    3008021110-2023-00115
    Event Type
    Injury
    Date Received
    October 21, 2023
    Date of Event
    July 18, 2023
    Report Date
    March 6, 2024
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE INVOLVED LOT # 2313190 - STER. #2300118, NO PRE-EXISTING ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #'S. THE INVOLVED IMPLANT WAS NOT AVAILABLE TO BE RETURNED. POST OPERATIVE X RAYS WERE PROVIDED. DUE TO THE CHANGE OF SURGICAL PLAN AND IMPLANTATION OF THE TRIAL ULNAR STEM, THE PROVIDED POST OP X RAYS AND ALL OTHER DATA WERE SUBMITTED TO A MEDICAL EXPERT FOR EVALUATION. THE EVALUATION RESULTS STATED THAT: AS I UNDERSTAND THE MARKING ON ONE RADIOGRAPH, THE TRIAL COMPONENT IS A VERY SMALL PART OF THE CUSTOM-MADE TEA. I DO NOT ASSUME ANY CLINICAL PROBLEM IN THE LONG RUN, AS THE TRIAL IS STERILE AND MADE OF PROPER MATERIAL. OF COURSE, I CANNOT COMMENT ON SIZE AND TOLERANCES HERE. TO BE SAVE I WOULD RECOMMEND TO HAVE CLOSE RADIOGRAPHIC FOLLOW-UP ASSESSMENT, BUT I GUESS THAT IS WHAT THE TREATING SURGEON WILL DO ANYWAY FOR THIS CUSTOM-MADE TEA. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT; ·THE CHECK OF THE MANUFACTURING AND STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #. ·THE ROOT CAUSE WAS IDENTIFIED AS THE CUSTOM-MADE IMPLANT WAS DROPPED/FELL TO THE FLOOR AND BECAME UNSTERILE. ·THE RESULTS OF MEDICAL EVALUATION BY EXPERT. WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA THE EVENT REPORTED BY THE COMPLAINT SOURCE IS IMPLANT FELL TO THE FLOOR AND BECAME NONSTERILE. NO REVISION RATE IS TO BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Additional Manufacturer Narrative · 0

    WE WILL SUBMIT A FINAL MDR AFTER THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    A ELBOW SURGERY WAS PERFORMED ON (B)(6) 2023. THIS WAS A CUSTOM-MADE DEVICE - CMD-1325. DURING THE SURGERY THE ULNAR STEM 9618.15.07W LOT # 2313190 - STER. #2300118 IMPLANT FELL TO THE FLOOR AND BECAME NONSTERILE. THE HOSPITAL WOULD NOT ALLOW THE IMPLANT TO BE FLASH STERILIZED AND THEREFORE THE TRIAL ULNAR STEM IMPLANT WITH THE SAME DESIGN MADE OF STAINLESS STEEL WAS IMPLANTED. PATIENT - FEMALE DATE OF BIRTH - (B)(6)1948 EVENT HAPPENED IN USA. PATIENT HISTORY PRE-2018: PATIENT HAS HISTORY OF A THIRD PARTY LEFT TOTAL ELBOW ARTHROPLASTY AND HAS HAD NUMEROUS REVISIONS. SHE DID WELL BUT DEVELOPED FLUID BUILDUP AND RETURNED TO THE OR IN NOVEMBER 2018. (B)(6) 2018: 2 PROCEDURESTEA REVISION (THIRD-PARTY) DECEMBER 2018: RECURRENT DRAINAGE WITH POSITIVE CULTURES OF MRSE INFECTION JANUARY 2019: INCREASED PAIN WITH X-RAYS SHOWING SIGNS OF SMALL PERIPROSTHETIC FRACTURE. (B)(6) 2019: TEA REVISION, REMOVAL OF INFECTED HUMERAL IMPLANT OF SOFT TISSUE, MUSCLE, AND BONE, A TORNIER MEDIUM STEM WAS PLACED WITH SURGEONS NOTING THAT THIS WAS THE LONGEST STEM POSSIBLE. JUNE - JULY 2019: PATIENT HAD 2 FOLLOW-UPS AND HAS CONTINUED PAIN, DRAINAGE, AND LITTLE FUNCTIONAL IMPROVEMENT AND IS ON ORAL ANTIBIOTICS. (B)(6) 2019: TEA REMOVAL EXPLANATION AND PLACEMENT OF THIRD-PARTY ANTIBIOTIC HEMIARTHROPLASTY SPACER OCTOBER 2019: PATIENT SITUATION ALMOST UNCHANGED, CONTINUED PAIN WITH LITTLE FUNCTIONAL IMPROVEMENT (B)(6) 2019: RESECTION AND REMOVAL OF HEMIARTHROPLASTY WITH DIAGNOSIS OF CHRONIC OSTEOMYELITIS MARCH 2022: PATIENT STATUS POST NOVEMBER 2019 PROCEDURE, HAS BEEN USING A BRACE BUT THIS IS NOT HELPFUL AND DOES NOT PROVIDE FUNCTIONAL STABILITY, INTERESTED IN OTHER TREATMENT OPTIONS. SURGEONS COMMENTS AT THE TIME. FOLLOWING THIS, HE CONTACTED LIMA FOR A CUSTOM TEA.

    Description of Event or Problem · 0

    A ELBOW SURGERY WAS PERFORMED ON (B)(6), 2023. THIS WAS A CUSTOM-MADE DEVICE - CMD-1325. DURING THE SURGERY THE ULNAR STEM 9618.15.07W LOT # 2313190 - STER. #2300118 IMPLANT FELL TO THE FLOOR AND BECAME NONSTERILE. THE HOSPITAL WOULD NOT ALLOW THE IMPLANT TO BE FLASH STERILIZED AND THEREFORE THE TRIAL WITH THE SAME DESIGN MADE OF STAINLESS STEEL WAS IMPLANTED. PATIENT - FEMALE. DATE OF BIRTH - (B)(6) 1948. EVENT HAPPENED IN USA. PATIENT HISTORY PRE-2018: PATIENT HAS HISTORY OF A THIRD PARTY LEFT TOTAL ELBOW ARTHROPLASTY AND HAS HAD NUMEROUS REVISIONS. SHE DID WELL BUT DEVELOPED FLUID BUILDUP AND RETURNED TO THE OR IN (B)(6) 2018. (B)(6) 2018: 2 PROCEDURES I&D + TEA REVISION (THIRD-PARTY). (B)(6) 2019: TEA REVISION, REMOVAL OF INFECTED HUMERAL IMPLANT + I&D OF SOFT TISSUE, MUSCLE, AND BONE, A TORNIER MEDIUM STEM WAS PLACED. (B)(6) 2019: TEA REMOVAL EXPLANATION AND PLACEMENT OF THIRD-PARTY ANTIBIOTIC HEMIARTHROPLASTY SPACER. (B)(6) 2019: RESECTION AND REMOVAL OF HEMIARTHROPLASTY WITH DIAGNOSIS OF CHRONIC OSTEOMYELITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983407 CMD 22-1325 ULNAR STEM CMD 22-1325 ULNAR STEM - CUSTOM MADE JDB LIMACORPORATE S.P.A 9618.15.07W 2313190

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other